Job Description

JOB SCOPE

• Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority.
• Communicate with sites, Lilly functions, clinical research organization to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
• Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
• Compose initial Informed Consent Form or amendments based on country ICF template as well as response to queries by Ethic Committees.
• Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
• Populate internal clinical trial systems (e.g., Vault Clinical, Shared Investigator Platform, IMPACT) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
• Ensure complete, accurate and readily available Trial Master File.

REQUIREMENT:

• At least bachelor\xe2\x80\x99s degree preferably in a scientific or health related field, postgraduate degree is also welcomed.
• 1-4 years clinical research experience or relevant experience preferred.
• Understanding of the overall clinical development paradigm and the importance of efficient site activation.
• Applied knowledge of project management processes and skills.
• Appreciation of / experience in compliance-driven environment.
• Self-management, able to multitask and good organizational skills.
• Language capabilities \xe2\x80\x93 English (read, write, conversation).

Job Type: Full-time
Contract length: 12 months Salary: RM3,800.00 - RM9,000.00 per month Benefits:

• Dental insurance
• Health insurance
• Maternity leave
• Meal allowance
• Opportunities for promotion

Schedule:

• Monday to Friday

Supplemental pay types:

• Performance bonus
• Yearly bonus

Ability to commute/relocate:

• Kuala Lumpur: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor\'s (Preferred)

Experience:

• Research Associates: 1 year (Preferred)